BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DIMI RRT Unit

    Reg #: 3015472042 · FEI: 3015472042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    I-DIALCO INC.
    Registration Number
    3015472042
    FEI Number
    3015472042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2455 Cawthra Road, Unit 23
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K193005

    Owner / Operator

    Firm Name
    i-Dialco Inc
    Operator Number
    10060385
    Address
    2455 Cawthra Road, Unit 23
    City
    Mississauga
    State
    Ontario
    Postal Code
    L5A 3P1
    Country
    CA
    Correspondent
    Jerome Bacani

    US Agent

    Business Name
    Medicsense USA LLC
    Contact Name
    George Hattub
    Address
    291 Hillside Avenue
    City
    Somerset
    State
    MA
    ZIP
    02726
    Country
    US
    Email
    [email protected]
    Phone
    508 4796116

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    DIMI RRT Unit

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198